UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013828 |
|---|---|
| Receipt number | R000015731 |
| Scientific Title | new strategy for malignant transformation of mature cystic teratoma |
| Date of disclosure of the study information | 2014/05/20 |
| Last modified on | 2016/05/16 02:28:32 |
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Basic information
Public title
new strategy for malignant transformation of mature cystic teratoma
Acronym
new strategy for malignant transformation of mature cystic teratoma
Scientific Title
new strategy for malignant transformation of mature cystic teratoma
Scientific Title:Acronym
new strategy for malignant transformation of mature cystic teratoma
Region
| Japan |
Condition
Condition
ovarian mature cystic teratoma with malignant transformation
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of concurrent chemoradiation or chemotherapy for ovarian mature cystic teratoma with malignant transformation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
OS
Key secondary outcomes
DFS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
concurrent chemoradiation for Ovarian cancer with Stage I, or II
Interventions/Control_2
intra-venous chemotherapy using Paclitaxel, Cisplatin, and 5-FU for Ovarian cancer with stage III or IV
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
ovary is surgically removed,and diagnosed of malignant transformation of ovarian mature cystic teratoma
squamous cell carcinoma
be able to get informed concent by document
Key exclusion criteria
past or present history of therapy for other malignancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yoshikawa |
Organization
University of Tsukuba
Division name
DIvision of medicine
Zip code
Address
1-1-1 Tennnotdai Tsukuba city
TEL
029-853-3073
monuki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamiko Onuki |
Organization
University of Tsukuba
Division name
DIvision of medicine
Zip code
Address
1-1-1 Tennnotdai Tsukuba city
TEL
029-853-3073
Homepage URL
monuki@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 28 | Day |
Last modified on
| 2016 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015731
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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